Articles Tagged With:
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New Tools to Facilitate Single IRB Process
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
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IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
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Updated Tactics for Parkinson’s Disease Study Recruitment
Remote, decentralized studies allow for the recruitment of large, geographically dispersed cohorts from a single location. In considering whether to use a decentralized design or to include remote assessments, the research team must determine if these methods can adequately answer the question under study.
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For Individualized Therapy Trials, Remain Mindful of Transparency, Reporting Bias
Individualized therapy studies should be publicly and prospectively registered in a clinical trial database. The authors should report results regardless of outcomes. If these trials are not handled right, it might be a step backward in terms of transparency and reporting bias.
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Leapfrog Group Addresses Diagnostic Errors with 29 Best Practices
A new report includes 29 actions hospitals can implement to reduce the risk of patient harm or death from diagnostic errors. The Leapfrog Group recently released what it calls a landmark report, Recognizing Excellence in Diagnosis: Recommended Practices for Hospitals. It was derived from a year of research with clinicians, health plans, and employers.
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New Checklist Offers Roadmap for Improved Diagnostic Performance
Emergency clinicians spend much time making diagnoses, but knowing they are right is another matter. The Society to Improve Diagnosis in Medicine reports missed or delayed diagnoses are a major public health problem, leading to higher costs, malpractice claims, and potentially adverse outcomes for patients.
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CMS Issues First Fines for Noncompliance with Transparency Rule
CMS has issued the first fines for violations of the Hospital Price Transparency Rule, and more penalties are expected. The first two hospitals fined for violations of the rule, both in Georgia, received written warnings and were allowed more than four months to bring their operations in compliance with the rule.
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Physician Phone Consultation Leads to Potential Liability
This case is an example of how a physician-patient relationship can be formed, even when no direct contact occurs between the physician and patient, or even when the physician is informally consulted by phone.
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Hospital EDs May See Legal Issues After Abortion Ruling
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, sending the issue of abortion rights back to the states, could lead to difficult legal situations for some EDs. Risk managers should consider their state laws and plan for potential issues. One of the first issues to consider is how laws restricting abortion intersect with EMTALA.
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Patient's Gangrene Results in Amputation, Hospital's Potential Liability
In this case, evidentiary concerns presented material issues for the defendant hospital, which was disputing liability early in the litigation.